N/A
N=523
Wood Stove Interventions and Child Respiratory Health
Lower Tract Respiratory Infection
Bottom Line
View on ClinicalTrials.gov: NCT02240134 ↗Enrolled (actual)
523
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Number of Participants With at Least One LRTI During Follow-up Period — 16; 20; 17; 138 Participants — p=0.68
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education Intervention (Tx1) (Behavioral); Air Filtration Unit Treatment (Tx2) (Device); Placebo Intervention (Tx3) (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Montana
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least One LRTI During Follow-up Period |
16; 20; 17; 138; 136; 134 | 0.68 |
| SECONDARY Fine Particulate Matter Concentrations |
36; 30; 32 | 0.250 |
Summary
Acute lower respiratory tract infections (LRTIs) account for more than 27% of all hospitalizations among US children under five years of age, with recurrent LRTIs in children a recognized risk factor for asthma. Residential biomass combustion leads to elevated indoor levels of fine particulate matter (PM2.5) that often exceed current health-based air quality standards. PM2.5 exposure is associated with many adverse health outcomes, including a greater than three-fold increased risk of LRTIs. To date, exposure reduction strategies in wood stove homes have been either inconsistently effective or include factors that limit widespread dissemination and continued compliance in rural and economically disadvantaged populations. In this project, the investigators propose to test the efficacy of two intervention strategies for reducing indoor wood smoke PM2.5 exposures and children's risk of LRTI in three unique and underserved settings: (1) rural mountain valley communities in western Montana; (2) Navajo Nation communities; and (3) Alaska Native Villages. The investigators will conduct a three-arm randomized placebo-controlled post-only intervention trial in wood stove homes with children less than five years old. Education on best-burn practices and training on the use of simple instruments (i.e., stove thermometers and wood moisture meters) will be introduced as one intervention arm (Tx1). This intervention will be evaluated against an indoor air filtration unit arm (Tx2), as well as a placebo arm (Tx3, sham air filters). The primary outcome will be LRTI incidence among children under five years of age. To allow for detection of exposure and outcome differences within each of the three regions, a sample of 324 homes, or 108 within each study area will be equally assigned to each of the three intervention arms. The overall hypothesis is that a low-cost, educational intervention targeting indoor wood smoke PM2.5 exposures will be sustainable, and can reduce children's risk of LRTI in underserved Native and rural communities.
Eligibility Criteria
Inclusion Criteria
- Eligible homes will be any home in the described communities that uses a wood stove as a primary heating source, and has one or more children under the age of five years. The home must include a parent who is capable and willing to record symptom data for the enrolled children and wood stove usage data.
Exclusion Criteria
- None.
Data sourced from ClinicalTrials.gov (NCT02240134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.